+

WO1996013251A1 - Procede de preparation de formes galeniques solides de substances hydrophobes - Google Patents

Procede de preparation de formes galeniques solides de substances hydrophobes Download PDF

Info

Publication number
WO1996013251A1
WO1996013251A1 PCT/GB1995/002485 GB9502485W WO9613251A1 WO 1996013251 A1 WO1996013251 A1 WO 1996013251A1 GB 9502485 W GB9502485 W GB 9502485W WO 9613251 A1 WO9613251 A1 WO 9613251A1
Authority
WO
WIPO (PCT)
Prior art keywords
solvent
units
pharmaceutically active
active substance
hydrophobic
Prior art date
Application number
PCT/GB1995/002485
Other languages
English (en)
Inventor
Richard John Yarwood
Patrick Kearney
Andrew Roy Thompson
Original Assignee
R.P. Scherer Corporation
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Application filed by R.P. Scherer Corporation filed Critical R.P. Scherer Corporation
Priority to PL95315181A priority Critical patent/PL187254B1/pl
Priority to DK95934711T priority patent/DK0737064T3/da
Priority to JP8514378A priority patent/JPH09511255A/ja
Priority to AU37027/95A priority patent/AU3702795A/en
Priority to AT95934711T priority patent/ATE198982T1/de
Priority to EP95934711A priority patent/EP0737064B1/fr
Priority to MX9602515A priority patent/MX9602515A/es
Priority to US08/663,103 priority patent/US5827541A/en
Priority to DE69520036T priority patent/DE69520036T2/de
Publication of WO1996013251A1 publication Critical patent/WO1996013251A1/fr
Priority to GR20010400258T priority patent/GR3035427T3/el

Links

Classifications

    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00—Medicinal preparations characterised by special physical form
    • A61K9/20—Pills, tablets, discs, rods
    • A61K9/2095—Tabletting processes; Dosage units made by direct compression of powders or specially processed granules, by eliminating solvents, by melt-extrusion, by injection molding, by 3D printing
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00—Medicinal preparations characterised by special physical form
    • A61K9/0012—Galenical forms characterised by the site of application
    • A61K9/0053—Mouth and digestive tract, i.e. intraoral and peroral administration
    • A61K9/0056—Mouth soluble or dispersible forms; Suckable, eatable, chewable coherent forms; Forms rapidly disintegrating in the mouth; Lozenges; Lollipops; Bite capsules; Baked products; Baits or other oral forms for animals

Definitions

  • the present invention relates to a process for preparing solid pharmaceutical dosage forms and, in particular, to a process for preparing an oral solid rapidly disintegrating dosage form of a pharmaceutically active substance.
  • Many pharmaceutically active substances are presented for oral administration in the form of tablets, pills or capsules.
  • the tablet, pill or capsule generally has to be swallowed with water so that the pharmaceutically active substance can be absorbed via the gastro-intestinal tract.
  • pill or capsule is difficult or impossible and this is particularly the case for paediatric patients and geriatic patients.
  • a similar difficulty is often encountered when trying to administer tablets to non-human animals which may be uncooperative in taking tablets, pills or capsules.
  • the solid dosage forms as disclosed comprise an open matrix network carrying the pharmaceutically active substance, the open matrix comprising a water-soluble or water-dispersible carrier material which is inert towards the pharmaceutically active substance.
  • the solid dosage forms are prepared by the sublimation or removal of solvent from a solution or suspension comprising the pharmaceutically active substance and the carrier material. Sublimation or removal of solvent is preferably carried out by freeze drying.
  • oral solid pharmaceutical dosage forms which rapidly disintegrate in the mouth are disclosed in US-A-5039540, US-A-5120549, US-A-5330763 , PCT/JP93/01631 and PCT/US93/12566.
  • the solid dosage forms which are produced by these various methods rapidly disintegrate on being placed in the mouth of the patient, thereby delivering the desired dose of the pharmaceutically active substance.
  • the preparation of oral solid rapidly dispersing dosage forms generally involves the formation of a suspension of the drug in water, optionally together with a co-solvent such as alcohol, together with the matrix forming components.
  • the present invention provides a process for the preparation of an oral rapidly disintegrating dosage form of a hydrophobic pharmaceutically active substance which process comprises forming a suspension of the hydrophobic pharmaceutically active substance in a solvent containing a pharmaceutically acceptable surfactant together with a water-soluble or water-dispersible carrier material, forming discrete units of the suspension and removing solvent from the discrete units under conditions whereby a network of the carrier material carrying a dosage of the hydrophobic pharmaceutically active substance is formed.
  • rapidly disintegrating as used herein is meant that the solid dosage form will disintegrate in water at 37 C in 60 seconds or less, preferably 5 to 10 seconds or less when tested by the following procedure which is analogous to the Disintegration Test for Tablets, B.P. 1973 and which is described in British Patent No. 1548022:-
  • the basket is suspended centrally in the cylinder in such a way that it can be raised and lowered repeatedly in a uniform manner so that at the highest position the gauze just breaks the surface of the water and at the lowest position the upper rim of the basket just remains clear of the water.
  • Method Place one shaped article in the basket and raise and lower it in such a manner that the complete up and down movement is repeated at a rate equivalent to thirty times a minute.
  • the shaped articles are disintegrated when no particle remains above the gauze which would not readily pass through it.
  • the pharmaceutical dosage form of the invention On oral administration of the solid dosage form of the invention to a patient the pharmaceutical dosage form rapidly disintegrates in the mouth.
  • the incorporation of the surfactant into the solvent used during the preparation of the suspension of the drug prevents the formation of a foam on mixing and ensures uniformity of the content of the drug in the dosage units and thus overcomes problems associated with air entrapment.
  • hydrophobic pharmaceutically active substances do not generally disperse easily and rapidly in the mouth and the addition of the surfactant during the processing of the drug improves the dispersion of the dosage units formed in the process of the invention within the mouth. Furthermore, for some hydrophobic pharmaceutically active substances the addition of the surfactant during processing improves the bioavailability of the product due to improved wetting of the pharmaceutically active substance leading to further dissolution and absorption.
  • any surfactant which fulfils the requirement of pharmaceutical acceptability may be used in the invention.
  • Particularly suitable surfactants for use in the present invention are the Poloxamers which are Q-hydro-co-hydroxypoly (oxyethylene) -poly (oxyethy- lene) block copoly ers and polysorbates which are polyoxyethylene derivatives of sorbitan esters. Since the surfactant will remain in the finished dosage form of the product it is important that it has an acceptable taste.
  • the process of the present invention is of particular use for the preparation of oral solid rapidly disintegrating dosage forms of hydrophobic pharmaceutically active agents which have a very small particle size since the ease of wetting becomes more difficult in the absence of a surfactant as the particle size decreases and the air entrapment during mixing in the absence of a surfactant becomes greater.
  • the present invention is thus of particular utility in preparing solid rapidly disintegrating dosage forms of hydrophobic pharmaceutically active agents having an average particle size of less than less than 50 ⁇ m, generally of less than 20 ⁇ m, more preferably less than 10 ⁇ m.
  • Hydrophobic pharmaceutically active agents which may be processed according to the present invention include do peridone and bromocriptine mesylate.
  • the discrete units of the suspension may be in the form of liquid units, for example contained within the pockets of a suitable mould, solid units, for example frozen units, or gelled units where the carrier material readily forms a gel.
  • the discrete units When the discrete units are in liquid form they will generally be frozen or gelled prior to drying.
  • the liquid suspension which may be contained within the pockets of a suitable mould is frozen, for example by passing a gaseous cooling medium, such as liquid nitrogen over the mould, or by inserting the mould into a nitrogen spray freezing chamber, or cooling by passing the mould over a cold surface.
  • a gaseous cooling medium such as liquid nitrogen over the mould
  • the mould Once the dosage forms have been frozen, the mould may be stored in a cold store, prior to drying.
  • Frozen discrete units may be dried by freeze drying according to techniques which are well known in the art.
  • the solvent is sublimed in a freeze drying process under a reduced pressure which transforms the solid solvent directly into a vapour.
  • freeze drying process will generally be carried out in a freeze drying chamber typically operating under a vacuum of 0.1 to 1.0 mBar for a period of time of from 180 to 500 minutes.
  • frozen discrete units may be dried by a process as described in US Patents Nos. 5120549 and 5330763.
  • the pharmaceutically active substance and carrier material dispersed in a first solvent is solidified and the solidified matrix is subsequently contacted with a second solvent that is substantially miscible with the first solvent at a temperature lower than the solidification point of the first solvent, the matrix component being substantially insoluble in the second solvent, the first solvent thereby being removed from the matrix.
  • Another alternative process for drying frozen discrete units is described in W094/14422.
  • the solvent is removed under conditions whereby the solvent is evaporatated from the solid through the liquid phase to a gas, rather than subliming from a solid to a gas as in lyophilization. This is achieved by vacuum drying at a temperature below the equilibrium freezing point of the composition at which point the solvent (such as water) changes phase.
  • any drying methods can be used which do not affect the properties of the preparations.
  • drying may be carried out at decreased pressure, or by forced-air drying. Drying at decreased pressure is preferably carried out at a temperature of from 25 to 35°C under a vacuum of -750mm Hg or less, for 2 to 5 hours, whilst drying using forced-air drying is preferably carried out at a temperature of from 3 to 15°C for 1 to 6 days.
  • the solvent used in forming the suspension of the pharmaceutically active substance is preferably water but it may be admixed with a co-solvent, such as alcohol, if desired.
  • the carrier material which is used to form the network containing the pharmaceutically active substance may be any water-soluble or water- dispersible material that is pharmaceutically acceptable, inert to the pharmaceutically active substance and which is capable of forming a rapidly disintegrating network.
  • the preferred carrier material for use in the present invention is gelatin, preferably pharmaceutical grade gelatin.
  • Other materials may also be used, for example hydrolysed dextrose, dextran, dextrin, maltodextrin, alginates, hydroxyethylcellulose, sodium carboxymethylcellulose, microcrystalline cellulose, corn-syrup solids, pectin, carrogeenan, agar, chitosan, locust bean gum, xanthan gum, guar gum, acacia gum, tragacanth, konjac fluor, rice flour, wheat gluten, sodium starch glycolate, soy fibre protein, potato protein, papain, horse radish peroxidase, glycine or mannitol.
  • the suspension prepared according to the process of the present invention is preferably formed into discrete units by introduction into a mould which preferably comprises a plurality of depressions, each depression being of the desired shape and size for the oral dosage form product.
  • the mould preferably comprises a plurality of depressions formed in a sheet of a filmic material which may be similar to the material employed conventionally in the blister packaging of pharmaceuticals.
  • a particularly preferred filmic material for use as a mould in the present invention is described in W094/12142.
  • the desired quantities of the suspension may be filled into the mould using an automatic filling means which delivers a predetermined dose into each of the depressions in the mould.
  • a covering material may be adhered to the filmic material in the area surrounding the depressions after the removal of solvent from the suspension filling the depressions.
  • the covering sheet is preferably an aluminium foil or aluminium foil laminate which may be adhered to the filmic material around the depressions by, for example a heat sensitive material.
  • the cover sheet may be adhered to the filmic material in a manner such that it can be peeled away by the user to uncover the oral dosage form in the depression in the mould or, alternatively, it may be adapted for the oral dosage formed to be pushed through.
  • Alternative methods of forming discrete frozen or gelled units of the suspension include solidifying the mixtures in dropwise fashion.
  • the suspension may be passed through one or more holes to form drops, spheres or a spray of small particles which can be solidified by passage through a cold gas or liquid, for example liquid nitrogen.
  • the drops, spheres or spray may be solidified by contact with a chilled liquid which is immiscible with the suspension and which has a density such that the drops either fall through the immiscible liquid as they solidify, or float on the surface of the immiscible liquid.
  • the suspension prepared in accordance with the process of the present invention may also contain other additional ingredients such as colouring agents, flavouring agents, sweetening agents or preservatives, or fillers such as mannitol or sorbitol which improve the physical properties of the oral dosage form.
  • additional ingredients such as colouring agents, flavouring agents, sweetening agents or preservatives, or fillers such as mannitol or sorbitol which improve the physical properties of the oral dosage form.
  • the present invention also includes within its scope the oral solid rapidly disintegrating dosage forms prepared according to the process of the invention.
  • Domperidone was formulated in the form of the free base into an oral rapidly disintegrating dosage form using the following ingredients.
  • a solution containing the gelatin, mannitol and Poloxamer 183 was prepared and to this were added the aspartame and mint flavouring. Aliquots of the resulting solution were added to the domperidone powder and a paste formed on stirring. The remainder of the solution was added and a homogeneous suspension was obtained. The suspension was dispensed in 150 mg aliquots into the pockets of a blister pack, frozen and dried to produce the final dosage form. The bioavailability of the domperidone final dosage form finished product was equivalent to that of a compressed tablet form containing the same quantity of domperidone. The bioavalability of a similar oral rapidly disintegrated product prepared without the Poloxamer surfactant was not, however, equivalent to that of the compressed tablet.

Landscapes

  • Health & Medical Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Veterinary Medicine (AREA)
  • Public Health (AREA)
  • Chemical & Material Sciences (AREA)
  • Medicinal Chemistry (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Epidemiology (AREA)
  • Animal Behavior & Ethology (AREA)
  • General Health & Medical Sciences (AREA)
  • Nutrition Science (AREA)
  • Physiology (AREA)
  • Zoology (AREA)
  • Medicinal Preparation (AREA)
  • Acyclic And Carbocyclic Compounds In Medicinal Compositions (AREA)
  • Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)

Abstract

On décrit un procédé de préparation d'une forme galénique orale, se désagrégeant rapidement, d'une substance hydrophobe, active sur le plan pharmacologique, ce procédé comprenant les étapes consistant à former, dans un solvant contenant un tensioactif acceptable sur le plan pharmacologique, une suspension de ladite substance active avec un excipient soluble dans l'eau ou ayant une bonne dispersibilité dans celle-ci, à former des unités différentes de la suspension et à enlever le solvant de ces unités dans des conditions permettant la formation d'un réseau de l'excipient portant un dosage de la substance hydrophobe, active sur le plan pharmacologique.
PCT/GB1995/002485 1994-10-28 1995-10-20 Procede de preparation de formes galeniques solides de substances hydrophobes WO1996013251A1 (fr)

Priority Applications (10)

Application Number Priority Date Filing Date Title
PL95315181A PL187254B1 (pl) 1994-10-28 1995-10-20 Sposób wytwarzania stałej doustnej, szybko rozpadającej się postaci dawki hydrofobowej, farmaceutycznie aktywnej substancji w postaci proszku oraz doustna, szybko rozpadająca się dawka w postaci ciała stałego
DK95934711T DK0737064T3 (da) 1994-10-28 1995-10-20 Fremgangsmåde til fremstilling af faste farmaceutiske doseringsformer af hydrofobe stoffer
JP8514378A JPH09511255A (ja) 1994-10-28 1995-10-20 疎水性物質を含む固形の薬用調剤形態の製法
AU37027/95A AU3702795A (en) 1994-10-28 1995-10-20 Process for preparing solid pharmaceutical dosage forms of hydrophobic substances
AT95934711T ATE198982T1 (de) 1994-10-28 1995-10-20 Verfahren zur herstellung von festen pharmazeutischen dosierungsformen hydrophobischen substanzen
EP95934711A EP0737064B1 (fr) 1994-10-28 1995-10-20 Procede de preparation de formes galeniques solides de substances hydrophobes
MX9602515A MX9602515A (es) 1994-10-28 1995-10-20 Procedimiento para preparar formas de dosis farmaceuticas de substancias hidrofobicas.
US08/663,103 US5827541A (en) 1994-10-28 1995-10-20 Process for preparing solid pharmaceutical dosage forms of hydrophobic substances
DE69520036T DE69520036T2 (de) 1994-10-28 1995-10-20 Verfahren zur herstellung von festen pharmazeutischen dosierungsformen hydrophobischen substanzen
GR20010400258T GR3035427T3 (en) 1994-10-28 2001-02-16 Process for preparing solid pharmaceutical dosage forms of hydrophobic substances

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
GB9421836A GB9421836D0 (en) 1994-10-28 1994-10-28 Process for preparing solid pharmaceutical dosage forms of hydrophobic substances
GB9421836.9 1994-10-28

Publications (1)

Publication Number Publication Date
WO1996013251A1 true WO1996013251A1 (fr) 1996-05-09

Family

ID=10763606

Family Applications (1)

Application Number Title Priority Date Filing Date
PCT/GB1995/002485 WO1996013251A1 (fr) 1994-10-28 1995-10-20 Procede de preparation de formes galeniques solides de substances hydrophobes

Country Status (16)

Country Link
US (1) US5827541A (fr)
EP (1) EP0737064B1 (fr)
JP (1) JPH09511255A (fr)
KR (1) KR100352881B1 (fr)
CN (1) CN1236762C (fr)
AT (1) ATE198982T1 (fr)
AU (1) AU3702795A (fr)
DE (1) DE69520036T2 (fr)
DK (1) DK0737064T3 (fr)
ES (1) ES2154737T3 (fr)
GB (1) GB9421836D0 (fr)
GR (1) GR3035427T3 (fr)
MX (1) MX9602515A (fr)
PL (1) PL187254B1 (fr)
PT (1) PT737064E (fr)
WO (1) WO1996013251A1 (fr)

Cited By (11)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO1997006786A1 (fr) * 1995-08-18 1997-02-27 R.P. Scherer Limited Compositions a dissolution rapide et administrees par voie orale, pour agonistes de la dopamine
WO1998035656A1 (fr) * 1997-02-12 1998-08-20 R. P. Scherer Corporation Procede de preparation de formes galeniques solides
JP2001509478A (ja) * 1997-07-11 2001-07-24 アールピー シェラー コーポレイション 迅速分散性固形経口投与用剤形の製造方法
WO2001087264A3 (fr) * 2000-05-18 2002-06-20 Elan Pharma Int Ltd Forme galenique orale solide a desintegration rapide
FR2845914A1 (fr) * 2002-10-18 2004-04-23 Schwarz Pharma Lab Compose antiemetique a desagregation rapide
US6852337B2 (en) 1998-04-09 2005-02-08 Roche Diagnostics Gmbh Carvedilol-galenics
FR2909877A1 (fr) * 2006-12-13 2008-06-20 Galenix Dev Soc Par Actions Si Composition pharmaceutique contenat de la 5-chloro-1-[1-[3- (2-oxo-2,3-dihydro-1h-benzimidazol-1-yl)propyl] piperidin-4-yl]-1,3-dihydro-2h-benzimidazol-2-one et son procede de preparation
US8236352B2 (en) 1998-10-01 2012-08-07 Alkermes Pharma Ireland Limited Glipizide compositions
WO2013165902A1 (fr) * 2012-04-30 2013-11-07 Veroscience Llc Formulations de bromocriptine
US9352025B2 (en) 2009-06-05 2016-05-31 Veroscience Llc Combination of dopamine agonists plus first phase insulin secretagogues for the treatment of metabolic disorders
US9364515B2 (en) 2002-08-09 2016-06-14 Veroscience Llc Therapeutic process for the treatment of the metabolic syndrome and associated metabolic disorders

Families Citing this family (54)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US6277458B1 (en) * 1999-03-15 2001-08-21 The Procter & Gamble Company Release strip with partible break to facilitate
US20040013613A1 (en) * 2001-05-18 2004-01-22 Jain Rajeev A Rapidly disintegrating solid oral dosage form
KR20010073232A (ko) 1998-11-20 2001-07-31 추후제출 분산성 인지질로 안정화된 마이크로입자
WO2002085337A1 (fr) 2001-04-20 2002-10-31 The University Of British Columbia Systemes d'administration de medicament micellaire pour medicaments hydrophobes
US20010053791A1 (en) * 2000-03-16 2001-12-20 Babcock Walter C. Glycogen phosphorylase inhibitor
CN1469707A (zh) * 2000-08-10 2004-01-21 �¶���˹ҩƷ��˾ 改进的疏水性药物的固体药物剂量制剂
US6814978B2 (en) 2000-12-29 2004-11-09 Mcneil-Ppc, Inc. Process for preparing a soft tablet
ATE331512T1 (de) 2001-01-26 2006-07-15 Schering Corp Verwendung azetidinone-substituierter verbindungen zur behandlung der sitosterolhämie
US7071181B2 (en) 2001-01-26 2006-07-04 Schering Corporation Methods and therapeutic combinations for the treatment of diabetes using sterol absorption inhibitors
CA2562982C (fr) 2001-01-26 2011-03-15 Schering Corporation Combinaisons d'activateur(s) du recepteur active par le proliferateur de peroxysome et d'inhibiteur(s) d'absorption des sterols, et traitements pour troubles vasculaires
AU2002240755B2 (en) * 2001-03-13 2007-07-05 Angiotech International Ag Micellar drug delivery vehicles and uses thereof
US20030157170A1 (en) * 2001-03-13 2003-08-21 Richard Liggins Micellar drug delivery vehicles and precursors thereto and uses thereof
HUP0401022A3 (en) * 2001-08-14 2006-11-28 Biotie Therapies Corp Method for the preparation of pharmaceutical compositions containing opioid antagonist for treating alcoholism or alcohol abuse
PT1429756E (pt) 2001-09-21 2007-01-31 Schering Corp Tratamento de xantoma com derivados de azetidinona como inibidores de absorção de esteróis
US7053080B2 (en) 2001-09-21 2006-05-30 Schering Corporation Methods and therapeutic combinations for the treatment of obesity using sterol absorption inhibitors
DK1443912T3 (da) * 2001-10-12 2008-01-21 Elan Pharma Int Ltd Sammensætninger med en kombination af umiddelbare og kontrollerede frisætningsegenskaber
EP1941878A1 (fr) 2002-01-10 2008-07-09 Biovail Laboratories International Srl Formules sédatives sans benzodiazépine
RU2004123621A (ru) * 2002-02-01 2005-04-10 Пфайзер Продактс Инк. (Us) Лекарственные формы с немедленным высвобождением, содержащие твердые дисперсии лекарств
CA2479735C (fr) * 2002-03-20 2011-05-17 Elan Pharma International Ltd. Formes posologiques a dissolution rapide presentant une friabilite reduite
AU2003256284A1 (en) * 2002-06-20 2004-01-06 Orapharma, Inc. Rapidly disintegrating formulations for treating or preventing mucositis
MXPA05004811A (es) 2002-11-06 2005-07-22 Schering Corp Inhibidores de absorcion de colesterol para el tratamiento de trastornos autoinmunes.
EP1585502B9 (fr) * 2002-11-12 2012-05-09 Elan Pharma International Limited Formes posologiques solides a desintegration rapide non friables et comprenant du pullulane
JP2006519869A (ja) * 2003-03-07 2006-08-31 シェーリング　コーポレイション 置換アゼチジノン化合物、置換アゼチジノン化合物を調製するためのプロセス、それらの処方物および使用
ATE418551T1 (de) 2003-03-07 2009-01-15 Schering Corp Substituierte azetidinon-derivate, deren pharmazeutische formulierungen und deren verwendung zur behandlung von hypercholesterolemia
US7459442B2 (en) 2003-03-07 2008-12-02 Schering Corporation Substituted azetidinone compounds, processes for preparing the same, formulations and uses thereof
DE602004016123D1 (de) 2003-03-07 2008-10-09 Schering Corp Substituierte azetidinon-derivate, deren pharmazeutische formulierungen und deren verwendung zur behandlung von hypercholesterolemia
US20040224024A1 (en) * 2003-04-23 2004-11-11 Massachusetts Institute Of Technology Controlled drug release formulations containing polyion complexes
US20050036977A1 (en) * 2003-08-11 2005-02-17 Dilip Gole Taste-masked resinate and preparation thereof
WO2005046707A1 (fr) 2003-11-10 2005-05-26 Fein Seymour H Compositions pharmaceutiques comportant de la desmopressine faiblement dosee
DE20321887U1 (de) 2003-11-10 2012-01-20 Allergan, Inc. Arzneimittel umfassend niedrige Dosierungen von Desmopressin
EP1586313A1 (fr) * 2004-04-07 2005-10-19 The Jordanian Pharmaceutical Manufacturing Co. Ltd. Compositions pharmaceutiques comprenant de la métoclopramine, et méthode de preparation
EP1910384B1 (fr) 2005-08-04 2012-10-10 Sirtris Pharmaceuticals, Inc. Dérivés d'imidazo [2,1-b]thiazole en tant que modulateurs de sirtuine
BRPI0620578A2 (pt) * 2005-12-27 2011-12-06 Jubilant Organosys Ltd composição farmacêutica que dissolve na boca e processo para o preparo da mesma
US20070243248A1 (en) * 2006-04-14 2007-10-18 Cherukuri S Rao Rapidly disintegrating solid oral dosage form of liquid dispersions
US20070259040A1 (en) * 2006-05-01 2007-11-08 Cherukuri S R Novel triptan formulations and methods for making them
WO2007143676A2 (fr) * 2006-06-05 2007-12-13 Verus Pharmaceuticals, Inc. Posologies d'epinéphrine comprenant des formes pharmaceutiques buccales, linguales ou sublinguales
TW200816985A (en) * 2006-06-05 2008-04-16 Verus Pharmaceuticals Inc Methods for buccal, lingual or sublingual dosing regimens of epinephrine for the treatment of allergic emergencies
US20080039433A1 (en) * 2006-06-15 2008-02-14 Smith Alexander D Stabilized Tetracycline Compositions
WO2011026080A1 (fr) 2009-08-31 2011-03-03 Wilmington Pharmaceuticals, Llc Compositions à désintégration rapide de méloxicame, procédés pour sa fabrication et utilisation pour traiter l'arthrite et/ou la douleur
EP2359812A1 (fr) 2010-01-18 2011-08-24 Cephalon France Compositions orales lyophilisées
TR201002084A1 (tr) 2010-03-19 2011-10-21 Sanovel İlaç Sanayi̇ Ve Ti̇caret Anoni̇m Şi̇rketi̇ Oral yolla dağılan donepezil tablet formülasyonları ve hazırlama yöntemi
EP2377522B1 (fr) 2010-04-15 2013-01-16 Sanovel Ilaç Sanayi Ve Ticaret Anonim Sirketi Formulations de comprimé à désintégration orale de mirtazapine et procédé de préparation.
CN103189358A (zh) 2010-09-01 2013-07-03 艾尼纳制药公司 5-ht2c激动剂的快速溶解剂型
EP2609911A1 (fr) 2011-12-29 2013-07-03 Sanovel Ilac Sanayi ve Ticaret A.S. Nouveau procédé de préparation de formulations de flurbiprofène se désintégrant oralement
FR2997766B1 (fr) * 2012-11-08 2015-06-12 Alain Iltis Systeme et procede de detection de rayonnement gamma de type gamma camera
RU2706727C2 (ru) 2014-09-17 2019-11-20 Стирлайф Индия Прайвит Лимитед Шипучие композиции и способы их получения и применения
US11219594B2 (en) 2015-12-12 2022-01-11 Steerlife India Private Limited Effervescent compositions of metformin and processes for preparation thereof
CN105560199B (zh) * 2016-03-01 2018-07-06 山东司邦得制药有限公司 一种小儿多潘立酮口崩片及其制备方法
CN105663055B (zh) * 2016-03-01 2018-07-06 山东司邦得制药有限公司 一种小儿多潘立酮干混悬剂及其制备方法
KR20190108104A (ko) 2016-12-31 2019-09-23 바이오엑셀 테라퓨틱스 인코포레이티드 불안의 치료를 위한 설하 덱스메데토미딘의 용도
CZ307916B6 (cs) 2017-05-08 2019-08-21 mcePharma s. r. o. Orodispergovatelná tableta s biodostupným kurkuminem a její použití
MX2020014000A (es) 2018-06-27 2021-06-15 Bioxcel Therapeutics Inc Formulaciones en lámina que contienen dexmedetomidina y métodos para producirlas.
KR20220049526A (ko) 2019-07-19 2022-04-21 바이오엑셀 테라퓨틱스 인코포레이티드 비-진정성 덱스메데토미딘 치료 양생법
US11806334B1 (en) 2023-01-12 2023-11-07 Bioxcel Therapeutics, Inc. Non-sedating dexmedetomidine treatment regimens

Citations (7)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
FR2366835A1 (fr) * 1976-10-06 1978-05-05 Wyeth John & Brother Ltd Element de forme destine a renfermer une substance chimique, son procede de preparation et emballage le contenant
GB1548022A (en) * 1976-10-06 1979-07-04 Wyeth John & Brother Ltd Pharmaceutial dosage forms
EP0159237A1 (fr) * 1984-03-30 1985-10-23 LABORATOIRE L. LAFON Société anonyme dite: Forme galénique pour administration orale et son procédé de préparation par lyophilisation d'une émulsion huile-dans-eau
US5039540A (en) * 1989-08-14 1991-08-13 Neophore Technologies, Inc. Freeze dry composition and method for oral administration of drugs, biologicals, nutrients and foodstuffs
EP0450141A1 (fr) * 1989-08-14 1991-10-09 Janssen Pharmaceutica Inc. Matériau support pour l'administration de médicaments
FR2661610A1 (fr) * 1990-05-02 1991-11-08 Rhone Poulenc Sante Nouvelle forme lyophilisee de la diosmine et sa preparation.
EP0578823A1 (fr) * 1991-04-08 1994-01-19 Sumitomo Pharmaceuticals Company, Limited Preparation solide poreuse contenant une substance proteique physiologiquement active

Family Cites Families (4)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
GB2111423B (en) * 1981-12-02 1985-06-26 Wyeth John & Brother Ltd Making quick-dissolving pills
EP0081921A1 (fr) * 1981-12-10 1983-06-22 Hawker Siddeley Revenue Controls Limited Système à carte de crédit
MX9300110A (es) * 1992-01-13 1994-07-29 Gerhard Gergely Preparacion farmaceutica en la forma de una tableta de efervescencia o de desintegracion o de un granulado de tipo instanteneo y procedimiento para su preparacion.
TW272942B (fr) * 1993-02-10 1996-03-21 Takeda Pharm Industry Co Ltd

Patent Citations (7)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
FR2366835A1 (fr) * 1976-10-06 1978-05-05 Wyeth John & Brother Ltd Element de forme destine a renfermer une substance chimique, son procede de preparation et emballage le contenant
GB1548022A (en) * 1976-10-06 1979-07-04 Wyeth John & Brother Ltd Pharmaceutial dosage forms
EP0159237A1 (fr) * 1984-03-30 1985-10-23 LABORATOIRE L. LAFON Société anonyme dite: Forme galénique pour administration orale et son procédé de préparation par lyophilisation d'une émulsion huile-dans-eau
US5039540A (en) * 1989-08-14 1991-08-13 Neophore Technologies, Inc. Freeze dry composition and method for oral administration of drugs, biologicals, nutrients and foodstuffs
EP0450141A1 (fr) * 1989-08-14 1991-10-09 Janssen Pharmaceutica Inc. Matériau support pour l'administration de médicaments
FR2661610A1 (fr) * 1990-05-02 1991-11-08 Rhone Poulenc Sante Nouvelle forme lyophilisee de la diosmine et sa preparation.
EP0578823A1 (fr) * 1991-04-08 1994-01-19 Sumitomo Pharmaceuticals Company, Limited Preparation solide poreuse contenant une substance proteique physiologiquement active

Cited By (32)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US6316027B1 (en) 1995-08-18 2001-11-13 R. P. Scherer Technologies, Inc. Fast-dissolving dosage forms for dopamine agonists
WO1997006786A1 (fr) * 1995-08-18 1997-02-27 R.P. Scherer Limited Compositions a dissolution rapide et administrees par voie orale, pour agonistes de la dopamine
WO1998035656A1 (fr) * 1997-02-12 1998-08-20 R. P. Scherer Corporation Procede de preparation de formes galeniques solides
US6156339A (en) * 1997-02-12 2000-12-05 R.P. Scherer Corporation Process for preparing solid pharmaceutical dosage forms
JP2001509478A (ja) * 1997-07-11 2001-07-24 アールピー シェラー コーポレイション 迅速分散性固形経口投与用剤形の製造方法
US6852337B2 (en) 1998-04-09 2005-02-08 Roche Diagnostics Gmbh Carvedilol-galenics
US8236352B2 (en) 1998-10-01 2012-08-07 Alkermes Pharma Ireland Limited Glipizide compositions
WO2001087264A3 (fr) * 2000-05-18 2002-06-20 Elan Pharma Int Ltd Forme galenique orale solide a desintegration rapide
US9364515B2 (en) 2002-08-09 2016-06-14 Veroscience Llc Therapeutic process for the treatment of the metabolic syndrome and associated metabolic disorders
US9999653B2 (en) 2002-08-09 2018-06-19 Veroscience Llc Therapeutic process for the treatment of the metabolic syndrome and associated metabolic disorders
FR2845914A1 (fr) * 2002-10-18 2004-04-23 Schwarz Pharma Lab Compose antiemetique a desagregation rapide
FR2909877A1 (fr) * 2006-12-13 2008-06-20 Galenix Dev Soc Par Actions Si Composition pharmaceutique contenat de la 5-chloro-1-[1-[3- (2-oxo-2,3-dihydro-1h-benzimidazol-1-yl)propyl] piperidin-4-yl]-1,3-dihydro-2h-benzimidazol-2-one et son procede de preparation
EP1935412A3 (fr) * 2006-12-13 2011-05-04 Galenix Developpement Composition pharmaceutique contenant de la 5-chloro-1-[1-[3-(2-oxo-2,3-dihydro-1H-benzimidazol-1-yl)propyl]pipéridin-4-yl]-1,3-dihydro-2H-benzimidazol-2-one et son procede de preparation
US10688155B2 (en) 2009-06-05 2020-06-23 Veroscience Llc Combination of dopamine agonists plus first phase insulin secretagogues for the treatment of metabolic disorders
US9895422B2 (en) 2009-06-05 2018-02-20 Veroscience Llc Combination of dopamine agonists plus first phase insulin secretagogues for the treatment of metabolic disorders
US9352025B2 (en) 2009-06-05 2016-05-31 Veroscience Llc Combination of dopamine agonists plus first phase insulin secretagogues for the treatment of metabolic disorders
US10307421B2 (en) 2012-04-30 2019-06-04 Veroscience Llc Bromocriptine formulations
WO2013165902A1 (fr) * 2012-04-30 2013-11-07 Veroscience Llc Formulations de bromocriptine
US9700555B2 (en) 2012-04-30 2017-07-11 Veroscience Llc Bromocriptine formulations
AU2016202572B2 (en) * 2012-04-30 2018-02-01 Veroscience Llc Bromocriptine formulations
US9192576B2 (en) 2012-04-30 2015-11-24 Veroscience Llc Bromocriptine formulations
AU2013256558B2 (en) * 2012-04-30 2016-01-28 Veroscience Llc Bromocriptine formulations
US9993474B2 (en) 2012-04-30 2018-06-12 Veroscience Llc Bromocriptine formulations
US9522117B2 (en) 2012-04-30 2016-12-20 Veroscience Llc Bromocriptine formulations
AU2018203021B2 (en) * 2012-04-30 2020-02-06 Veroscience Llc Bromocriptine formulations
EP3620155A1 (fr) * 2012-04-30 2020-03-11 VeroScience LLC Formulations de bromocriptine
US10688094B2 (en) 2012-04-30 2020-06-23 Veroscience Llc Bromocriptine formulations
US8613947B2 (en) 2012-04-30 2013-12-24 Veroscience Llc Bromocriptine formulations
US11000522B2 (en) 2012-04-30 2021-05-11 Veroscience Llc Bromocriptine formulations
EP3960160A1 (fr) * 2012-04-30 2022-03-02 VeroScience LLC Formulations de bromocriptine
US11666567B2 (en) 2012-04-30 2023-06-06 Veroscience Llc Bromocriptine formulations
EP4342536A3 (fr) * 2012-04-30 2024-06-26 VeroScience LLC Formulations de bromocriptine

Also Published As

Publication number Publication date
DK0737064T3 (da) 2001-02-26
JPH09511255A (ja) 1997-11-11
MX9602515A (es) 1997-05-31
CN1140408A (zh) 1997-01-15
PL315181A1 (en) 1996-10-14
PT737064E (pt) 2001-05-31
DE69520036T2 (de) 2001-06-21
US5827541A (en) 1998-10-27
KR100352881B1 (ko) 2003-01-06
EP0737064B1 (fr) 2001-01-31
PL187254B1 (pl) 2004-06-30
ES2154737T3 (es) 2001-04-16
GB9421836D0 (en) 1994-12-14
EP0737064A1 (fr) 1996-10-16
DE69520036D1 (de) 2001-03-08
GR3035427T3 (en) 2001-05-31
CN1236762C (zh) 2006-01-18
ATE198982T1 (de) 2001-02-15
AU3702795A (en) 1996-05-23

Similar Documents

Publication Publication Date Title
US5827541A (en) Process for preparing solid pharmaceutical dosage forms of hydrophobic substances
EP0737065B1 (fr) Procede de preparation de formes galeniques solides
US5837287A (en) Process for preparing solid pharmaceutical dosage forms
JP2550362B2 (ja) スプレードライしたアセトアミノフェン
US5976577A (en) Process for preparing fast dispersing solid oral dosage form
CA1083042A (fr) Forme pharmaceutiques pour administration par voie orale
TW402561B (en) Process for the preparation of a solid rapidly disintegrating dosage form and the dosage form prepared thereby
JP2542400B2 (ja) スプレ―ドライしたアセトアミノフェン
IE45770B1 (en) Pharmaceutical dosage forms
WO2000051593A2 (fr) Systeme d'administration de medicament par voie buccale
WO2002047607A2 (fr) Procede de preparation d'une forme posologique rapidement soluble
US6726928B2 (en) Process for preparing solid dosage forms for unpalatable pharmaceuticals
US6770300B1 (en) Rapidly decomposing chitosan-based pellets
KR100355060B1 (ko) 고체약제투여형을제조하는방법

Legal Events

Date Code Title Description
WWE Wipo information: entry into national phase

Ref document number: 95191626.2

Country of ref document: CN

AK Designated states

Kind code of ref document: A1

Designated state(s): AM AT AU BB BG BR BY CA CH CN CZ DE DK EE ES FI GB GE HU IS JP KE KG KP KR KZ LK LR LT LU LV MD MG MK MN MW MX NO NZ PL PT RO RU SD SE SG SI SK TJ TM TT UA UG US UZ VN

AL Designated countries for regional patents

Kind code of ref document: A1

Designated state(s): KE MW SD SZ UG AT BE CH DE DK ES FR GB GR IE IT LU MC NL PT SE BF BJ CF CG CI CM GA GN ML MR NE SN TD TG

WWE Wipo information: entry into national phase

Ref document number: 1995934711

Country of ref document: EP

WWE Wipo information: entry into national phase

Ref document number: 1019960703488

Country of ref document: KR

WWE Wipo information: entry into national phase

Ref document number: 08663103

Country of ref document: US

121 Ep: the epo has been informed by wipo that ep was designated in this application
WWP Wipo information: published in national office

Ref document number: 1995934711

Country of ref document: EP

REG Reference to national code

Ref country code: DE

Ref legal event code: 8642

NENP Non-entry into the national phase

Ref country code: CA

WWG Wipo information: grant in national office

Ref document number: 1995934711

Country of ref document: EP

点击 这是indexloc提供的php浏览器服务，不要输入任何密码和下载